Abstract
In the present study,we examined whether distilled water or tap water affects the release of the major component from the tablet in the simple suspension method.We first analyzed hospital tap water for the presence of 22 different elements and 11 of them (B,Na,Mg,Ca,Ni,Fe,Cu,Zn,Ba,Mn and Cd) were detected.However,the concentrations of all these elements were below the limits prescribed by the water quality standards for drinking water specified in the Waterworks Law of Japan.We then studied the release of amlodipine besilate from the originator product containing it as the active ingredient and 5 generic versions using the simple suspension method.The amlodipine contents of the originator product and generics were 98.2-101.7%,within the range specified in the Japanese Pharmacopoeia.After suspending in distilled water for 30 and 120 min,the amounts of amlodipine released from the originator drug were 15 and 38%,respectively.Those for generics at 30 and 120 min were similar to the originator except for one generic which was designed to release the active ingredient in the mouth.In conclusion,for the simple suspension method,the amounts of amlodipine released from originator drug with time into water were similar to those for generics.
